Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01044602
Eligibility Criteria:
Inclusion Criteria:
* Age 25 to 70
* BMI 35 or greater
* HbA1c\>6.5%
* Stable weight
* Stable medications
Exclusion Criteria:
* Coagulopathy
* Liver cirrhosis
* C-peptide \<1 ng/ml (off insulin)
* Diagnosis of severe eating disorder
* Untreated endocrine disorder
* Use of medication for weight loss in the past 6 months
* Use of medication for weight loss in the last 6 months (with the exception of orlistat)
* Pregnancy
* Coagulopathy
* Liver cirrhosis
* Incurable, malignant, or debilitating disease
* Severe eating disorder
* Use of weight loss medication in the last 6 months, with the exception of orlistat
* Untreated endocrine disorder
* Pregnant
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT01044602
Study Brief:
Protocol Section:
NCT01044602